Omnicef

   
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Omnicef


Drug - Omnicef
The trade name of the product as shown on the labeling.

Dosage - FOR SUSPENSION; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cefdinir
Multiple ingredients are in alphabetical order.

Strength - 125MG/5ML
The potency of the active ingredient(s), Cefdinir. May repeat for multiple part products.

Applicant - ABBOTT
The firm name holding legal responsibility for Omnicef. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050749
The FDA assigned number to Omnicef. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Omnicef. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 4, 1997
The date Omnicef was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Omnicef. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Omnicef is in. Format is RX, OTC, DISCN.

Applicant Full Name - Abbott Laboratories
The full name of the firm holding legal responsibility for the new application of Omnicef.

Omnicef